MoonLake Immunotherapeutics plans to submit an FDA Biologics License Application for Sonelokimab in hidradenitis suppurativa by the end of September following a positive pre-BLA meeting. The submission is supported by clinical trial data showing 43% of patients achieved high-level improvement by Week 12 in the Mira trial. The company is also expecting multiple Phase 3 data readouts throughout the year.
MoonLake Immunotherapeutics announced positive topline results from its Phase 2 S-OLARIS trial of sonelokimab in axial spondyloarthritis, with 81% of patients achieving ASAS40 response by Week 12. The company ended Q4 2025 with $394 million in cash.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07223138 |
A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Psoriatic Arthritis |
ENROLLING_BY_INVITATION | PHASE3 |
| NCT07007637 |
A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa |
ENROLLING_BY_INVITATION | PHASE3 |
| NCT06641089 |
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response |
RECRUITING | PHASE3 |
| NCT06641076 |
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT06411899 |
A Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa |
COMPLETED | PHASE3 |
| NCT06411379 |
Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa |
COMPLETED | PHASE3 |
